Administrative Policy Statement WEST VIRGINIA MARKETPLACE PLAN Contents of Policy

Administrative Policy Statement WEST VIRGINIA MARKETPLACE PLAN Policy Name Policy Number Date Effective Site of Care for Drug Administration PAD-0023-WV-MPP 03/01/2020 Policy Type Medical ADMINISTRATIVE Pharmacy Reimbursement

Administrative Policy Statements prepared by CSMG Co. and its affiliates (including CareSource) are derived from literature based on and supported by clinical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standards, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without which the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area, are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manuals, Member Handbooks, and/or other policies and procedures.

Administrative Policy Statements prepared by CSMG Co. and its affiliates (including CareSource) do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Administrative Policy Statement. If there is a conflict between the Administrative Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determination.

Contents of Policy ADMINISTRATIVE POLICY STATEMENT ...... 1 TABLE OF CONTENTS ...... 1 A. SUBJECT ...... 2 B. BACKGROUND ...... 2 C. DEFINITIONS...... 2 D. POLICY ...... 2 E. CONDITIONS OF COVERAGE ...... 5 F. RELATED POLICIES/RULES ...... 5 G. REVIEW/REVISION HISTORY ...... 5 H. REFERENCES ...... 5

Pharmacy - Site of Care for Drug Administration West Virginia Marketplace Plan PAD-0023-WV-MPP Effective Date: 03/01/2020 A. SUBJECT This policy outlines required criteria for administration of drugs at the hospital outpatient setting as the site of service and directs members to the most cost-effective site of care. It also outlines medications to which this policy applies. B. BACKGROUND The CareSource Pharmacy Policy Statement is a guideline for determining site of care coverage for selected drugs. It is used as a tool to be interpreted in conjunction with the member's specific benefit plan. The intent of CareSource Site of Care for Drug Administration policy is to outline the requirements for coverage for the outpatient hospital drug administration. C. DEFINITIONS  Site of Care: Choice for physical location of infusion administration. Sites of Care include hospital inpatient, hospital outpatient, provider’s office, ambulatory infusion center, or home- based setting. D. POLICY This policy does not apply to the first administration of a drug. The first dose can be administered at any facility of the physician’s choice. All subsequent doses will be subject to the CareSource Site of Care for Drug Administration policy which requires the use of a non-hospital outpatient facility or home care setting.

Note: Therapy that consists of a single administration of a drug is considered the first administration.

I. CareSource considers outpatient hospital facility-based intravenous medication infusion necessary if member meets one of the following: A. Member is initiating therapy for the first time or therapy reinitiated after more than 6 months; B. Member has documentation of previously severe or potentially life-threatening adverse event (e.g., anaphylaxis, seizures, renal failure, etc.) during or following infusion of the prescribed medication, and the adverse event cannot be managed through pre-medication in the home or office setting; C. Member is medically unstable for administration of the therapy due to one of the following: 1. history of cardiopulmonary conditions 2. difficulty establishing and maintaining vascular access 3. physical or cognitive impairments that can cause an unnecessary health risk 4. unstable renal function; D. Medication requested is not available for administration at one of the following: 1. non-hospital outpatient facility 2. physician’s office 3. home-based setting 4. ambulatory infusion center;

II. CareSource requires subsequent doses of the following medications to be administered in a non-hospital outpatient facility, provider’s office, ambulatory infusion center or homesetting:

THERAPY DESCRIPTION CODE BRAND NAME Alpha-1 Deficiency J0256 Aralast NP, Prolastin, Zemaira Alpha-1 Deficiency J0257 Glassia Blood Cell Deficiency J0881 Aranesp Blood Cell Deficiency J0885 Epogen, Procrit

Pharmacy - Site of Care for Drug Administration West Virginia Marketplace Plan PAD-0023-WV-MPP Effective Date: 03/01/2020 THERAPY DESCRIPTION CODE BRAND NAME Blood Cell Deficiency J1447 Granix Blood Cell Deficiency J2820 Leukine Blood Cell Deficiency J2562 Mozobil Blood Cell Deficiency J2505 Neulasta Blood Cell Deficiency J1442 Neupogen Enzyme Deficiencies J1931 Aldurazyme Enzyme Deficiencies J1786 Cerezyme Endocrine Disorders J0584 Crysvita Enzyme Deficiencies J1743 Elaprase Enzyme Deficiencies J3060 Elelyso Enzyme Deficiencies J0180 Fabrazyme Enzyme Deficiencies J0221 Lumizyme Enzyme Deficiencies J3397 Mepsevii Enzyme Deficiencies J1458 Naglazyme Enzyme Deficiencies J1322 Vimizim Enzyme Deficiencies J3385 VPRIV Growth Deficiency J1930 Somatuline Depot Hemophila/Bleeding Disorders J7192 Advate Hemophila/Bleeding Disorders J7207 Adynovate Hemophila/Bleeding Disorders J7210 Afstyla Hemophila/Bleeding Disorders J7186 Alphanate Hemophila/Bleeding Disorders J7193 Alphanine Hemophila/Bleeding Disorders J7201 Alprolix Hemophila/Bleeding Disorders J7194 Bebulin Hemophila/Bleeding Disorders J7195 Benefix Hemophila/Bleeding Disorders J2724 Ceprotin Hemophila/Bleeding Disorders J7180 Corifact Hemophila/Bleeding Disorders J2597 DDAVP Hemophila/Bleeding Disorders J7205 Eloctate Hemophila/Bleeding Disorders J7198 Feiba NF Hemophila/Bleeding Disorders J7170 Hemlibra Hemophila/Bleeding Disorders J7192 Helixate FS Hemophila/Bleeding Disorders J7190 Hemofil M Hemophila/Bleeding Disorders J7187 Humate-P Hemophila/Bleeding Disorders J7202 Idelvion Hemophila/Bleeding Disorders J7198 Ixinity Hemophila/Bleeding Disorders J7199 Jivi Hemophila/Bleeding Disorders J7190 Koate-DVI Hemophila/Bleeding Disorders J7192 Kogenate Hemophila/Bleeding Disorders J7193 Mononine Hemophila/Bleeding Disorders J7182 Novoeight Hemophila/Bleeding Disorders J7189 Novoseven Hemophila/Bleeding Disorders J7209 Nuwiq Hemophila/Bleeding Disorders J7194 Profilinine Hemophila/Bleeding Disorders J7192 Recombinate Hemophila/Bleeding Disorders J7178 RiaSTAP Hemophila/Bleeding Disorders J7200 Rixubis

Pharmacy - Site of Care for Drug Administration West Virginia Marketplace Plan PAD-0023-WV-MPP Effective Date: 03/01/2020 THERAPY DESCRIPTION CODE BRAND NAME Hemophila/Bleeding Disorders J7181 Tretten Hemophila/Bleeding Disorders J7183 Wilate Hemophila/Bleeding Disorders J7185 Xyntha Hereditary Angioedema J0597 Berinert Hereditary Angioedema J0598 Cinryze Hereditary Angioedema J1744 Firazyr Hereditary Angioedema J0599 Haegarda Hereditary Angioedema J1290 Kalbitor Hereditary Angioedema J0596 Ruconest HIV J1746 Trogarzo Immune Deficiency J1566 Carimune NF Immune Deficiency J1555 Cuvitru Immune Deficiency J1569 Gammagard Liquid Immune Deficiency J1666 Gammagard S-D Immune Deficiency J1561 Gammaked Immune Deficiency J1557 Gammaplex Immune Deficiency J1561 Gamunex-C Immune Deficiency J1559 Hizentra Immune Deficiency J1575 HyQvia Immune Deficiency J1568 Octagam Immune Deficiency J1459 Privigen Inflammatory Conditions J3262 Actemra Inflammatory Conditions J0490 Benlysta Inflammatory Conditions J0717 Cimzia Inflammatory Conditions J3380 Entyvio Inflammatory Conditions J0638 Ilaris Inflammatory Conditions Q5103 Inflectra Inflammatory Conditions J0129 Orencia Inflammatory Conditions J1745 Remicade Inflammatory Conditions Q5104 Renflexis Inflammatory Conditions J1602 Simponi Aria Inflammatory Conditions J3358 Stelara IV Miscellaneous Diseases J0364 Apokyn Miscellaneous Diseases J3590 Myalept Miscellaneous Diseases J1300 Soliris Miscellaneous Diseases J1628 Tremfya Miscellaneous Diseases J3590 Ultomiris Multiple Sclerosis J0202 Lemtrada Multiple Sclerosis J2350 Ocrevus Multiple Sclerosis J2323 Tysabri Pulmonary Hypertension J1325 Flolan Pulmonary Hypertension J3285 Remodulin Pulmonary Hypertension J7686 Tyvaso Pulmonary Hypertension J1325 Veletri Pulmonary Hypertension Q4074 Ventavis Transplant J0485 Nulojix

Pharmacy - Site of Care for Drug Administration West Virginia Marketplace Plan PAD-0023-WV-MPP Effective Date: 03/01/2020

E. CONDITIONS OF COVERAGE As above. F. RELATED POLICIES/RULES Selected individual drug policies can be found at: https://www.caresource.com/wv/providers/tools-resources/health-partner- policies/pharmacy-policies/marketplace/ G. REVIEW/REVISION HISTORY DATES ACTION Date Issued 08/21/2019 Initial release Date Revised Date Effective 03/01/2020 Date Archived 09/01/2020

H. REFERENCES 1. Aralast NP [prescribing information]. Westlake Village, CA: Baxalta US Inc.; September 2015. 2. Glassia [prescribing information]. Lexington, MA: Baxalta US Inc.; June 2017. 3. Prolastin-C [prescribing information]. Research Triangle Park, NC: Grifols Therapeutics LLC; August 2018. 4. Zemaira [prescribing information].Kankakee, IL: CSL Behring LLC; September 2015. 5. Aranesp [prescribing information]. Thousand Oaks, CA: Amgen, Inc.; January 2019. 6. Epogen [prescribing information]. Thousand Oaks, CA: Amgen, Inc.; July 2018. 7. Procrit [prescribing information]. Thousand Oaks, CA: Amgen, Inc.; June 2011. 8. Granix [prescribing information]. North Wales, PA: Teva Pharmaceuticals USA, Inc.; March 2019. 9. Leukine [prescribing information]. Bridgewater, NJ: Sanofi-Aventis; February 2017. 10. Mozobil [prescribing information]. Cambridge, MA: Genzyme Corporation; May 2019. 11. Neulasta [prescribing information]. Thousand Oaks, CA: Amgen Inc.; April 2019. 12. Neupogen [prescribing information]. Thousand Oaks, CA: Amgen; June 2018. 13. Aldurazyme [prescribing information]. Cambridge, MA: Genzyme Corporation; April 2013. 14. Cerezyme [prescribing information]. Cambridge, MA: Genzyme Corporation; April, 2018. 15. Crysvita [prescribing information]. Novato, CA: Ultragenyx Pharmaceutical Inc.; April, 2018. 16. Elaprase [prescribing information]. Lexington, MA: Shire Human Genetic Therapies, Inc.; November 2018. 17. Elelyso [prescribing information]. New York, NY: Pfizer Inc.; December 2016. 18. Fabrazyme [prescribing information]. Cambridge, MA: Genzyme Corporation; December 2018. 19. Lumizyme [prescribing information]. Cambridge, MA: Genzyme Corporation; May 2019. 20. Mepsevii [prescribing information]. Novato, CA: Ultragenyx Pharmaceutical Inc.; November, 2017. 21. Naglazyme [prescribing information]. Novato, CA: BioMarin Pharmaceutical Inc.; March 2013. 22. Vimizim [prescribing information]. Novato, CA: BioMarin Pharmaceutical Inc.; February 2014. 23. VPRIV [prescribing information]. Lexington, MA: Shire Human Genetic Therapies, Inc.; July 2019. 24. Somatuline Depot [prescribing information]. Basking Ridge, NJ: Ipsen Pharma Biotech; June 2019. 25. Advate [prescribing information]. Westlake Village, CA: Baxalta US Inc; Nov 2016. 26. Adynovate [prescribing information]. Westlake Village, CA: Baxalta US Inc; March 2017. 27. Afstyla [prescribing information]. Kankakee, IL: CSL Behring LLC; Sept 2017. 28. Alphanate [prescribing information]. Los Angeles, CA: Grifols Biologicals Inc.; June 2014. 29. Alphanine SD [prescribing information]. Los Angeles, CA: Grifols Biologicals Inc.; March 2017. 30. Alprolix [prescribing information]. Cambridge, MA: Biogen Inc.; November 2017. 31. Bebulin VH [prescribing information]. Westlake Village, CA: Baxalta US Inc; July 2012. 32. Benefix [prescribing information]. Philadelphia, PA: Wyeth Pharmaceuticals Inc.; June 2017.

Pharmacy - Site of Care for Drug Administration West Virginia Marketplace Plan PAD-0023-WV-MPP Effective Date: 03/01/2020 33. Corifact [prescribing information]. Kankakee, IL: CSL Behring LLC; Sept 2017. 34. DDAVP [prescribing information]. Bridgewater, NJ: Sanofi-Aventis U.S.LLC.; July 2007. 35. Eloctate [prescribing information]. Waltham, MA: Bioverativ Therapeutics Inc.; Dec 2017. 36. Feiba [prescribing information]. Westlake Village, CA: Baxter Healthcare Corporation.; Nov 2013. 37. Feiba NF [prescribing information]. Westlake Village, CA: Baxter Healthcare Corporation.; Feb 2011. 38. Feiba VH [prescribing information]. Westlake Village, CA: Baxter Healthcare Corporation.; Apr 2005 39. Helixate FS [prescribing information]. Kankakee, IL: CSL Behring LLC.; May 2014. 40. Hemlibra [prescribing information]. South San Francisco, CA: Genentech, Inc.; Nov 2017 41. Hemofil M [prescribing information]. Westlake Village, CA: Baxter Healthcare Corporation.; April 2012. 42. Humate-P [prescribing information]. Kankakee, IL: CSL Behring LLC.; Aug 2013. 43. Idelvion [prescribing information]. Kankakee, IL: CSL Behring LLC.; March 2016. 44. Ixinity [prescribing information]. Berwyn, PA: Aptevo BioTherapeutics LLC; April 2018. 45. Kcentra [prescribing information]. Kankakee, IL: CSL Behring LLC.; Dec 2013. 46. Koate-DVI [prescribing information]. Los Angeles, CA: Grifols Biologicals Inc.; Aug 2012. 47. Kogenate FS [prescribing information]. Tarrytown, NY: Bayer Healthcare; May 2014. 48. Kovaltry [prescribing information]. Whippany, NJ: Bayer HealthCare LLC; March 2016. 49. Monoclate-P [prescribing information] Kankakee, IL: ZLB Behring LLC.; Aug 2004 50. Mononine [prescribing information]. Kankakee, IL: CSL Behring LLC.; Feb 2013. 51. Novoeight [prescribing information]. Plainsboro, NJ: Novo Nordisk Inc.; June 2018. 52. Novoseven RT [prescribing information]. Bagsvaerd, Denmark: Novo Nordisk A/S.; May 2014. 53. NuwiQ [prescribing information]. Hoboken, NJ: Octapharma USA Inc.; Sept 2015. 54. Obizur [prescribing information]. Westlake Village, CA: Baxter Healthcare Corporation.; Oct 2014 55. Profilnine [prescribing information]. Los Angeles, CA: Grifols Biologicals Inc.; Aug 2010. 56. Rebinyn [prescribing information]. Plainsboro, NJ: Novo Nordisk Inc.; May 2017. 57. Recombinate [prescribing information] Westlake Village, CA: Baxter Healthcare Corporation.; Dec 2010. 58. RiaSTAP [prescribing information] Kankakee, IL: CSL Behring LLC.; Dec 2011. 59. Rixubis [prescribing information]. Westlake Village, CA: Baxalta US Inc.; Sept 2014. 60. Tretten [prescribing information]. Bagsvaerd, Denmark: Novo Nordisk A/S.; Apr 2014. 61. VonVendi [prescribing information].Westlake Village, CA: Baxalta US Inc.; Dec 2015. 62. Wilate [prescribing information]. Hoboken, NJ: Octapharma USA Inc.; Aug 2010. 63. Xyntha [prescribing information]. Philadelphia, PA: Wyeth Pharmaceuticals Inc.; Oct 2014. 64. Jivi [prescribing information]. Whippany, NJ: Bayer HealthCare LLC; August 2018. 65. Berinert [prescribing information]. Kankakee, IL: CSL Behring LLC; September, 2016. 66. Cinryze [prescribing information]. Exton, PA; ViroPharma Biologics, Inc.; June 2018. 67. Firazyr [prescribing information]. Lexington, MA; Shire Orphan Therapies, Inc.; August 2011. 68. Haegarda [prescribing information]. Kankakee, IL: CSL Behring LLC; June 2017. 69. Kalbitor [prescribing information]. Burlington, MA; Dyax Corp.; September 2014. 70. Ruconest [prescribing information]. Raleigh, NC; Salix Pharmaceuticals, Inc.; July 2014. 71. Trogarzo [prescribing information]. Irvine, CA: TaiMed Biologics USA Corp.; March 2018. 72. Carimune NF [prescribing information]. Kankakee, IL: CSL Behring LLC; September 2013. 73. Cuvitru [prescribing information]. Westlake Village, CA: Baxalta US Inc.; September 2016. 74. Gammagard Liquid [prescribing information]. Westlake Village, CA: Baxter Healthcare Corporation; April 2014. 75. Gammagard S/D [prescribing information]. Westlake Village, CA: Baxter Healthcare Corporation; April 2014. 76. Gammaked [prescribing information]. Fort Lee, NJ: Kedrion Biopharma, Inc.; September 2013. 77. Gammaplex [prescribing information]. Hertfordshire, United Kingdom: Bio Products Laboratory; July 2015. 78. Gamunex-C [prescribing information]. Research Triangle Park, NC: Grifols Therapeutics Inc.; July 2014. 79. Octagam 10% [prescribing information]. Hoboken, NJ: Octapharma USA, Inc.; April 2015.

Pharmacy - Site of Care for Drug Administration West Virginia Marketplace Plan PAD-0023-WV-MPP Effective Date: 03/01/2020 80. Octagam 5% [prescribing information]. Hoboken, NJ: Octapharma USA, Inc.; October 2014. 81. Privigen [prescribing information]. Kankakee, IL: CSL Behring LLC; November 2013. 82. Hizentra [prescribing information]. Kankakee, IL: CSL Behring LLC; October 2016. 83. HyQvia [prescribing information]. Westlake Village, CA: Baxter Healthcare Corporation; September 2016. 84. Actemra [prescribing information]. South San Francisco, CA: Genentech, Inc.; 2018. 85. Benlysta [prescribing information]. Rockville, MD: Human Genome Sciences, Inc.; March 2011. 86. Cimzia [prescribing information]. Smyrna, GA: UCB, Inc.; May 2018. 87. Entyvio [prescribing information]. Deerfield, IL: Takeda Pharmaceuticals America, Inc.; May 2014. 88. Ilaris [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; December, 2016. 89. Inflectra [prescribing information]. New York, NY: Pfizer Inc,; June 2019. 90. Orencia [prescribing information]. Princeton, NJ: Bristol-Myers Squibb Company; March 2017. 91. Remicade [prescribing information]. Horsham, PA; Janssen Biotech, Inc.; January2015. 92. Renflexis [prescribing information]. Whitehouse Station, NJ: Merck & Co., Inc.; June 2019. 93. Simponi Aria [prescribing information]. Horsham, PA; Janssen Biotech, Inc.; October 2017. 94. Stelara [prescribing information]. Horsham, PA: Janssen Biotech Inc.; October 2017. 95. Apokyn [prescribing information]. Louisville, KY: US WorldMeds, LLC; May 2019. 96. Myalept [prescribing information]. Cambridge, MA: Aegerion Pharmaceuticals, Inc.; September 2015. 97. Soliris [prescribing information]. New Haven, CT: Alexion Pharmaceuticals Inc.; January 2017. 98. Tremfya [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; April 2019. 99. Ultomiris [prescribing information]. Boston, MA: Alexion Pharmaceuticals, Inc.; December 2018. 100. Lemtrada [prescribing information]. Cambridge, MA: Genzyme, Inc.; June 2016. 101. Ocrevus [prescribing information]. San Francisco, CA; Genentech, Inc,; March 2017. 102. Tysabri [prescribing information]. Cambridge, MA: Biogen, Inc.; December 2016. 103. Flolan [prescribing information]. Research Triangle Park, NC: GlaxoSmithKline; December 2018. 104. Remodulin [prescribing information]. Research Triangle Park, NC: United Therapeutics Corp; July 2018. 105. Tyvaso [prescribing information]. Research Triangle Park, NC: United Therapeutics Corp.; October 2017. 106. Veletri [prescribing information]. South San Francisco, CA: Actelion Pharmaceuticals US, Inc.; December 2018. 107. Ventavis [prescribing information]. South San Francisco, CA: Actelion Pharmaceuticals US, Inc.; October 2017. 108. Nulozif [prescribing information]. Princeton, NJ: Bristol-Myers Squibb Company; April 2018.